Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

Not Applicable

Completed

• Conditions: Uterine Cervical Neoplasms; Fallopian Tube Neoplasms; Urogenital Neoplasms; Uterine Neoplasms; Ovarian Neoplasms
• Interventions: Behavioral: Guided Imagery With Audio Media

• Registration Number: NCT02444195
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Primary Completion: 2016-05-01
• Study Completion: 2016-05-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Undergoing surgical management for a suspected diagnosis of Gynecologic Malignancy (Endometrial, Ovarian, Vulvar, Vaginal, Primary Peritoneal, Fallopian Tube)
• Age 18 or greater
• Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
• Able to understand and read English
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Patients must have working telephone, mobile or land line

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Exclusion Criteria

• Severe hearing impairment that limits the ability to use audio-based guided imagery modules
• Current documented alcohol abuse or illicit drug substance abuse
• Planned outpatient surgery
• Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided Imagery	Guided Imagery With Audio Media	Guided Imagery With Audio Media

Primary Outcome Measures

Name	Time	Method
Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.	postoperative day 1
Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.	6-8 week postoperative exam

Secondary Outcome Measures

Name	Time	Method
Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).	postoperative day 1 and 6-8 week postoperative exam
Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.	6-8 week postoperative visit
The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.	postoperative day 1 and 6-8 week postoperative exam
Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain	postoperative day 1 and 6-8 week postoperative exam
Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.	postoperative day 1 and 6-8 week postoperative exam
Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.	postoperative day 1 and 6-8 week postoperative exam
Effect of perioperative guided imagery on health care related locus of control, measured by the Multidimensional Health Locus of Control-form A (MHLC-A) questionnaire.	postoperative day 1 and 6-8 week postoperative exam
Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).	postoperative day 1 and 6-8 week postoperative exam

Trial Locations

Locations (1)

University of Michigan Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States